Validity of 1BPM for Diagnosis of Hypertension

Status Completed

Clinical Trial Summary

Blood pressure measurement methods and conditions are determinants of hypertension diagnosis. The classical methods such as office blood pressure measurement (OBPM) and home blood pressure monitoring (HBPM) have significant limitations. A recent British guideline recommends systematic 24-hour ambulatory blood pressure monitoring (ABPM). However, these devices are not available at all health centers and they can only be used by one patient per day. The aim this study is to validate a new method, 1-hour blood pressure monitoring (1BPM), to diagnose the hypertension.

Participants with suspected hypertension will be recruited from a population of patients seen at three primary health centers in an urban area. According to the sample size estimation, a minimum sample size of 214 participants would be needed for the study. Four diagnostic tests will be performed: OBPM at three visits, HBPM, AMPM and 1BPM. The test order for the 24-hour monitoring, and 1-hour monitoring, will be set randomly. Daytime records of ABPM will be compared to all other monitoring methods using the correlation coefficients and Bland Altman plots. The Kappa index will be used to calculate degree of agreement. The sensitivity and specificity of the methods will also be calculated.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Hypertension

Clinical Trial Details

NCT number	NCT03147573
Study type	Interventional
Source	Consorci d'Atenció Primària de Salut de l'Eixample
Contact
Status	Completed
Phase	N/A
Start date	June 1, 2017
Completion date	September 30, 2019

View Details

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